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Unrated Medical device recall · FDA · Published February 9, 2021

In2Bones Shannon Percutaneous Burr Recall: Possible Brr Breakage During Surgery

In2Bones recalls some Shannon Percutaneous Burrs (model G01 01511/01512) due to possible breakage during foot surgery, risking injury to patients.

🇺🇸 FDA recall #Z-1283-2021Medical deviceIn2Bones ›
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Recalling firmIn2Bones, SAS28 Chemin du petit Bois · Ecully, France
✎ GovInfoNow plain-language explainer

In2Bones is recalling specific models of Shannon Percutaneous Burrs that may break during surgery, potentially causing injury to patients. This recall affects medical devices used in foot procedures. Read more at govinfonow.com/recall/63285-in2bones-shannon-percutaneous-burr-recall-possible-brr-breakage-during-surgery.

Source Summary by GovInfoNow · govinfonow.com/recall/63285-in2bones-shannon-percutaneous-burr-recall-possible-brr-breakage-during-surgery · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1283-2021

Cite this page

“In2Bones Shannon Percutaneous Burr Recall: Possible Brr Breakage During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63285-in2bones-shannon-percutaneous-burr-recall-possible-brr-breakage-during-surgery. Based on FDA recall #Z-1283-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1283-2021%22&limit=1).

In2Bones, SAS voluntarily recalled In2Bones Shannon Percutaneous Burrs on Feb. 9, 2021, after the FDA identified manufacturing non-conformities that could cause breakage during use. The recall affects specific batches distributed in Tennessee.

How to tell if you have it

  • Brand: In2Bones
  • Product: Shannon Percutaneous Burr
  • Model G01 01511, Batches 2009139 and 2001089
  • Model G01 01512, Batches 2007087 and 2011062
  • Distribution: US Nationwide distribution in the state of TN

The hazard

The FDA said the recall follows the identification of manufacturing non-conformity in some batches of Shannon burrs with a diameter of 2.0mm and length of 20mm, which may cause the burr to break during use.

Context

GovInfoNow's records show In2Bones, SAS has two other recalls on record since July 13, 2017. On Jan. 26, 2024, the company issued a recall for I.B.S 6.5-C Compression Screws due to length mix-up risks. Other recent recalls of similar products include Surgify Halo 4.0mm Short Model 40.125.NVG.H1 (April 30, 2026), Surgify Halo 4.0mm Short Model 40.170.NVG.U1 (April 30, 2026), and Surgify Halo 3.0mm Drill (April 30, 2026).

How to tell if you have this one

Check for model numbers G01 01511 or G01 01512. Batches 2009139, 2001089, 2007087, and 2011062 are affected. These burrs are used for foot surgery procedures.

  • Brand
    In2Bones
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Model

    Identify if your burr is model G01 01511 or G01 01512.

  2. Contact Manufacturer

    Reach out to In2Bones for further guidance on the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution in the state of TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.4 years after the firm started it.

1. Firm started the recall: Feb 9, 202112. FDA classified it Class II: Mar 19, 202123. Published in FDA’s Enforcement Report: Mar 31, 202134. FDA terminated the recall: Jul 11, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1283-2021 (February 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1283-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA